Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis
NCT ID: NCT04768465
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2021-01-01
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Combined Immunotherapy
MG patients are treated with tacrolimus combined with low-dose prednisone (0.25mg/kg/d).
Symptomatic treatment like pyridostigmine bromide can be added to relieve symptoms (≤480mg/d).
Pyridostigmine, Prednisone, Tacrolimus
Dose of tacrolimus should be initiated based on CYP3A5\*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Prednisone is administrated with an initial dose of 0.25mg/kg/d and started to tamper with the achievement of MMS or the presence of any intolerable side effects. The rate of tampering is considered by the physician, usually no more than 5mg/month. If the participants failed to maintain MMS, dose of prednisone should be increased 5mg/week to 0.25mg/kg/d and maintained until MMS reached again. After MMS sustained for 1 month, prednisone dose would be tapered again with 2.5mg/month. Calcium and potassium supplements and gastric mucosa protectors could be addressed to avoid any adverse effects of prednisone. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.
Tacrolimus monotherapy
MG patients are treated with tacrolimus as initial immune monotherapy. Symptomatic treatment like pyridostigmine bromide can be added to relieve symptoms (≤480mg/d).
Pyridostigmine, Tacrolimus
Dose of tacrolimus should be initiated based on CYP3A5\*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.
Interventions
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Pyridostigmine, Prednisone, Tacrolimus
Dose of tacrolimus should be initiated based on CYP3A5\*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Prednisone is administrated with an initial dose of 0.25mg/kg/d and started to tamper with the achievement of MMS or the presence of any intolerable side effects. The rate of tampering is considered by the physician, usually no more than 5mg/month. If the participants failed to maintain MMS, dose of prednisone should be increased 5mg/week to 0.25mg/kg/d and maintained until MMS reached again. After MMS sustained for 1 month, prednisone dose would be tapered again with 2.5mg/month. Calcium and potassium supplements and gastric mucosa protectors could be addressed to avoid any adverse effects of prednisone. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.
Pyridostigmine, Tacrolimus
Dose of tacrolimus should be initiated based on CYP3A5\*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical Diagnosis of MG is confirmed based on typical clinical features of fluctuating muscle weakness, with at least 1 of the following supporting evidence:
1. positive clinical response to acetylcholinesterase inhibitor
2. positive AchR-Ab or MuSK-Ab testing
3. decrement \>10% in repetitive nerve stimulations study (RNS) or increased jitter on single-fibre electromyography (SFEMG)
* MGFA clinical classification: I - IV
* Baseline MG-ADL ≥ 3
* Disease course from onset to enrollment ≤ 12 months
* Cooperation to followup
* Written informed consent
Exclusion Criteria
* Treatment of immunosuppressant for other concomitant disease 6 months prior to recruitment
* Rapid immunosuppressive treatments like Intravenous immunoglobulin or plasma exchange 1 month prior to recruitment
* Thymectomy within 3 months prior to Screening
* Concomitant chronic degenerative, psychiatric, or neurologic disorder that can cause weakness or fatigue
* Consciousness, dementia or schizophrenia
* Pregnancy or lactation, unwillingness to avoid pregnancy
* Uncontrolled hypertension or diabetes, Liver or kidney dysfunction, Cataract, Severe osteoporosis, Femoral head necrosis; Hyperkalemia, HIV, Acute or chronic infection
* Other conditions that would preclude participation
18 Years
ALL
No
Sponsors
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Da, Yuwei, M.D.
INDIV
Responsible Party
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Principal Investigators
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Yuwei Da, M.D.
Role: STUDY_CHAIR
Xuanwu Hospital, Beijing
Locations
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Yuwei Da
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1.0
Identifier Type: -
Identifier Source: org_study_id
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